The purpose of this study is to evaluate the safety and tolerability of SA4503 in patients recovering from a recent stroke. Secondary, to evaluate the efficacy of SA4503 compared to placebo.
Further study details as provided by M's Science Corporation:
- SA4503 Drug
Intervention Desc: A potent and selective sigma-1 receptor agonist.
- Placebo Drug
Intervention Desc: Oral administration ARM 1: Kind: Experimental Label: P Description: Placebo
- SA4503 Low Drug
Intervention Desc: Oral administration ARM 1: Kind: Experimental Label: A1 Description: SA4503
- SA4503 High Drug
Intervention Desc: Oral administration ARM 1: Kind: Experimental Label: A2 Description: SA4503
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Eligible patients will be randomized to receive either SA4503 or placebo orally once daily for 28 days. Study duration will be 28 days of treatment with a 28-day follow-up period.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Safety and tolerability will be assessed by adverse events including clinical changes and abnormal laboratories at 28 days and 56 days.|
|Secondary||Efficacy endpoints will be NIHSS, Barthel Index, and modified Rankin Scale at 28 days and 56 days.|
|Primary||Safety and tolerability||4 weeks||Yes|